FANO – All the safety rules were respected on the occasion of the skipped surgery at otorhinolaryngology.
This is guaranteed by the medical director of the Marche Nord hospital, Maria Teresa Montella, who underlines the correctness of the work of the head physician of the Santa Croce ward, Giuseppe Migliori.
2 December 2014 – Corriere Adriatico
The hospital confirms that the episode, dating back to November 25, occurred because the drug package did not contain the product. Therefore, the photo of the unopened and empty bottle of Botox, the botulinum toxin used in the treatment of spasmodic hoarseness, is shown.
The bottle is transparent, but the medical director explains that, according to protocol, the sealed outer box was only opened at the time of surgery, when the operating room was ready and the patient, who suffers from involuntary contractions of the vocal cords, he had been locally anesthetized.
It was an exceptional event. "In 35 years of profession I had never found a bottle without the drug inside," says the chief physician Migliori.
“Doctor Giuseppe Migliori's behavior went beyond the quality and beyond the guideline – declares Maria Teresa Montella -. All international safety checklists have been complied with." The medical director also refers to the choice of the chief physician not to operate, for reasons of prudence, with the drug recovered on the occasion from the Pesaro hospital, through the 118, which would have required manual dilution of the active ingredient while the protocols prescribe an amount precise to the milligram, which is precisely that of Botox. Any mistake could have had serious consequences.
According to Maria Teresa Montella, there wasn't a supply of that drug because it costs 900/1,000 euros and a good health administrator gets one for each scheduled operation, because it can't be maintained.
The patient did not suffer any damage, according to the chief physician Migliori, even if he was sent home after a day of hospitalization without being able to be treated, with the same inability to speak due to spasmodic dysphonia that he had when he entered the hospital. "He was kept overnight not for the risks of local anesthesia - says the chief physician - but because I was trying to recover the drug for the next day".
For the health management of the Marche Nord hospital, which reports that it has reported the manufacturing defect of the medicine to the company and the ministry of health, the responsibility for the incident lies solely with the pharmaceutical cause.
Medical director and chief physician, in the press conference convened for the occasion, are unable to communicate who the Botox manufacturer is and not even after how long the drug expires.
Since the patient, who has already been operated on at the Santa Croce hospital where the rare pathology was diagnosed with merit, must undergo surgical therapy (with the injection of Botox into the muscles of the vocal cords) every 6/8 months, a reserve of the drug could be reused.
